A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455896
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
Intarcia Therapeutics

Brief Summary:
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ITCA 650 Other: ITCA placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes
Actual Study Start Date : March 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
Drug: ITCA 650
ITCA 650

ITCA placebo Other: ITCA placebo
ITCA placebo

Primary Outcome Measures :
  1. time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina), [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HBA1c > 6.5%
  • History of coronary, cerebrovascular or peripheral artery disease

Exclusion Criteria:

  • history of pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455896

  Hide Study Locations
United States, Arizona
Study Site
Chandler, Arizona, United States, 85224
United States, California
Intarcia Therapeutics, Inc
Hayward, California, United States, 94545
Study Site
Long Beach, California, United States, 90806
Study Site
Port Hueneme, California, United States, 93041
Study SIte
San Diego, California, United States, 92114
United States, Florida
Study Site
Bradenton, Florida, United States, 34208
Study Site
New Port Richey, Florida, United States, 34652
Study Site
Palm Harbor, Florida, United States, 34684
United States, Illinois
Study Site
Chicago, Illinois, United States, 60634
United States, Indiana
Study Site
Avon, Indiana, United States, 46123
Study Site
Evansville, Indiana, United States, 47714
Study Site
Franklin, Indiana, United States, 46131
Study Site
Greenfield, Indiana, United States, 46140
Study Site
Muncie, Indiana, United States, 47304
United States, Kansas
Study Site
Newton, Kansas, United States, 67114
Study Site
Wichita, Kansas, United States, 67205
Study Site
Wichita, Kansas, United States, 67207
United States, Louisiana
Study Site
Metaire, Louisiana, United States, 70006
United States, Michigan
Study Site
Rochester, Michigan, United States, 48307
United States, Missouri
Study Site
St Louis, Missouri, United States, 63141
United States, Montana
Study Site
Billings, Montana, United States, 59101
United States, Nevada
Study Site
Las Vegas, Nevada, United States, 89128
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Study Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Study Site
Cincinnati, Ohio, United States, 45236
Study Site
Columbus, Ohio, United States, 43213
Study Site
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Study Site
Pittsburgh, Pennsylvania, United States, 15236
Study Site
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Study Site
Greer, South Carolina, United States, 29651
United States, Texas
Study Site
Austin, Texas, United States, 78745
Dallas, Texas, United States, 75230
Study Site
Dallas, Texas, United States, 75231
Study Site
San Antonio, Texas, United States, 78229
Plovdiv, Bulgaria, 4002
Hvidovre, Denmark, 2650
Oulu, Finland, 90100
Bad Lauterberg im Harz, Niedersachsen, Germany, 37431
Sopot, Poland, 81-717
Martin, Slovakia, 03659
South Africa
Johannesburg, Gauteng, South Africa, 2193
Istanbul, Turkey, 34098
Sponsors and Collaborators
Intarcia Therapeutics

Responsible Party: Intarcia Therapeutics Identifier: NCT01455896     History of Changes
Other Study ID Numbers: ITCA 650-CLP-107
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists